Phoenix^SMSuccess Stories

Phoenix^SM has been successfully working with clients in the pharmaceutical, food, and medical device industries for many years. Here are a few of our success stories with the client's names omitted to ensure confidentiality.

	"We could not have achieved such a positive result (on our clinical data audits) without the "first rate work" of the Phoenix auditors."
	"Phoenix has played an important role in our achieving GCP compliance: In the past several years, we have successful undergone five FDA BIMO inspections without any 483s."
	We have provided expert witness consultation to many law firms regarding regulatory requirements. One attorney described a member of our team as follows: "(Phoenix's) expert witness in our medical device case was terrific, very responsive and testified well in deposition ... a pleasure to work with."
	Two Phoenix associates assisted a client with its foreign contract manufacturing site. One completed a mock FDA audit with a "wonderful demeanor" and "clear messages" to the client's vendor. The other associate helped the client build a quality system and worked with the client to prepare its vendor for a US FDA inspection. This associate was described as another "gem" from Phoenix.
	As part of Phoenix's ongoing electronic submission service, we submitted the first electronic food additive petition to FDA. This service expedited FDA's review of the submission.
	We have assisted four major drug/biologic companies that received consent decrees. As a result, three out of the four are no longer under a consent decree. All were allowed to continue marketing their products
	We have worked with many clients assisting in the preparation of premarket submissions to all FDA centers, including combination products involving more than one center. Our assistance has lightened our clients' internal workload and helped facilitate the agency review thereby reducing time to market.
	We have advised clients in the preparation of responses to FDA's 483s and Warning Letters. These efforts have resulted in positive FDA responses, assuring continued marketing of the clients' products and preventing additional enforcement actions.
	We have routinely conducted CGMP/QSR/GCP/GLP audits to include mock FDA PAI audits for NDA approval. For example, Phoenix has conducted PAI audits at multiple sites in Japan and Europe.. The client implemented our recommended corrective action which facilitated the sites meeting FDA requirements. The NDAs were approved.
	We have served as an effective independent auditor of medical device firms that have been placed on integrity hold. Our services have helped these firms respond to FDA concerns.
	Phoenix has conducted GCP audits for numerous clients and assisted them with corrective actions. The result: Successful FDA Bioresearch inspections!
	Phoenix has provided regulatory advice to US drug companies on adapting their development and registration plans to accommodate EU requirements, including setting up and managing meetings with EMEA and MHRA. Our European regulatory insight and assistance has facilitated global regulatory procedures for its US clients.
	In Japan, we serve as a valuable resource for the Japanese pharmaceutical industry. Using the presentation, "Points for Successful FDA Inspection," we have provided Japanese pharmaceutical companies with important facts in how to manage a successful FDA inspection. Our consulting services have facilitated many successful PAI inspections for Japanese companies.
	Our Japanese Associate has published several articles in the Pharm Tech Japan, Vol. 20 (2004), including the following: "Fundamentals of FDA Inspection," "Persons Receiving Investigators," "How to Deal with Investigators," and "General Affairs and Concrete Points to be Considered." These articles have provided the Japanese pharmaceutical industry with many helpful facts about the US FDA inspection procedures.

Announcements

Charma Konnor, R.Ph., RAC, Executive Director/Consultant, Devices and Drugs, was named Fellow of the Regulatory Affairs Professionals Society (RAPS). She was inducted in a ceremony on September 16, 2008.

Articles

Our Associate in Japan, Takashi Yamaoka, wrote an article about the recent US Food and Drug Administration final rule [73 FR 51919-51933; September 8, 2008] amending the CGMP for finished pharmaceuticals, for a popular Japanese pharmaceutical magazine, Pharm Tech Japan. The article was published on December 1, 2008. The final rule for the FDA requirements became effective December 8, 2008.

Want More Information on Successful Risk Management for Your Device and Diagnostics Company?

Please see the article, Expert Advises Companies on Successful Risk Management, from FDA News Device & Diagnostics Letter, featuring Phoenix's Charma Konnor, R.Ph., RAC, Executive Director/Consultant, Devices and Drugs.

Reprinted with permission, FDANews © 2005. FDANews. All Rights Reserved. www.fdanews.com

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